Sun.May 12, 2024

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Elite Runners Live Years Longer Than The Average Person, Scientists Find

AuroBlog - Aurous Healthcare Clinical Trials blog

Running 10 hours a week for more than 120 km (75 miles) is extreme exercise, to be sure. Yet far from pushing the body beyond its limits, a new study suggests some professional athletes are adding years to their lives with such brutal routines.

Scientist 200
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Could Cancer Vaccines Be the Next Big Breakthrough in Immunotherapy?

BioSpace

The race is on to develop therapeutic cancer vaccines that could give immunotherapies an edge, and late-stage trials could soon provide more-robust data about candidates’ efficacy and safety.

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Liposomal technology revolutionises pharma and nutraceutical industries in India

AuroBlog - Aurous Healthcare Clinical Trials blog

Indian pharma & nutraceutical industries see liposomal technology as a game-changer with the potential to improve drug efficacy and patient safety. This is particularly significant in the development of targeted therapies for conditions like cancer, where precise delivery of medication to specific cells or tissues is crucial.

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Sanofi, Pfizer, AstraZeneca Pledge Nearly $2.16B in Total Investments in France

BioSpace

The major biopharma players have promised to increase their investments in France to help boost their respective global manufacturing and R&D capabilities, with Sanofi committing more than $1 billion.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Mortality of Patients With Sepsis Administered Piperacillin-Tazobactam vs Cefepime

JAMA Internal Medicine

This cohort study compares 90-day mortality in patients with sepsis who received piperacillin-tazobactam vs cefepime for treatment of sepsis.

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Merck Ends Phase III Anti-TIGIT, Keytruda Skin Cancer Study with High Dropouts

BioSpace

A pre-planned analysis revealed patients receiving the vibostolimab-Keytruda coformulation in a late-stage trial had a high rate of dropouts due to immune-related adverse events, Merck announced Monday.

Trials 97

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Opinion: Travere’s Filspari Could Lead IgA Nephropathy Market

BioSpace

With its first-in-class endothelin and angiotensin II receptor antagonist Filspari, Travere Therapeutics is providing a more efficacious treatment option for the rare autoimmune disease.

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First recipient of pig kidney transplant dies

pharmaphorum

The first person to receive a xenotransplant of a kidney from a pig, Rick Slayman, has died almost two months after the procedure

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Excision’s CRISPR-Based HIV Treatment Fails to Show Curative Potential in Early Study

BioSpace

Results from a Phase I study presented Friday at the ASGCT 2024 annual meeting showed that despite a good safety profile, Excision BioTherapeutics’ HIV gene editor failed to suppress viral activity.

Gene 89
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Pfizer reaches deal with NICE on Vyndaqel for ATTR-CM

pharmaphorum

Pfizer reaches deal with NICE on Vyndaqel for ATTR-CM Phil.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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BIOSECURE Act Gets Update, Gives US Drugmakers Until 2032 to Sever Ties with Chinese Biotechs

BioSpace

An updated draft of the BIOSECURE Act introduced on Friday would give U.S. drug manufacturers additional leeway for existing contracts with certain Chinese “companies of concern” until 2032.

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Mail-Order Pharmacy Dispensing of Mifepristone for Abortion After In-Person Screening

JAMA Internal Medicine

This cohort study estimates the effectiveness, acceptability, and feasibility of dispensing mifepristone for medication abortion using a mail-order pharmacy.

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FDA Action Alert: Dynavax, Ascendis and BMS

BioSpace

The FDA is looking at five big decision deadlines in the coming three weeks, including two for a CAR-T therapy and another for a hepatitis B vaccine.

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Help Shape the Future of Eye Health: Your Child’s Participation Matters!

Trialfacts

Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details About the Research Centre Study Location Research Centre: UNSW School of Optometry & Vision Science Location: Rupert Myers Building (M15), Gate 14, Barker St, UNSW, Kensington NSW 2052, Australia Lead Researcher: Dr. Pauline King HREC: This study has been reviewed and approved by the UNSW Human Research Ethics Committee About the Study Has your child been diagnosed with myopia also known as shortsig

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Cut or Keep Running? How Companies Respond to Failed Confirmatory Trials

BioSpace

Amylyx’s recent decision to withdraw its ALS drug Relyvrio from the market highlights an important business decision for companies: when to continue marketing or investigating a drug that has failed a pivotal or confirmatory study.

Trials 84
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Drop Shipment Efficiency: Navigating Data Challenges in Indirect Partner Transactions

Pharmaceutical Commerce

This document details the benefits of DataX, a revolutionary solution tailored for pharmaceutical manufacturers. Designed to navigate the complexities of managing serialized data for drop shipments, DataX ensures secure, compliant, and efficient data exchange.

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Takeda Inks Potential $2.2B Deal for AC Immune’s Alzheimer’s Immunotherapy

BioSpace

Takeda on Monday said it is paying AC Immune $100 million upfront for an option on a Phase Ib/II Alzheimer’s disease candidate that could activate the immune system to clear amyloid beta plaques.

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Strategic EPCIS Implementation: Optimizing Supply Chain Management through Strategic EPCIS Implementation

Pharmaceutical Commerce

This document outlines key strategies and testing protocols critical for optimizing EPCIS implementation, ensuring that pharmaceutical manufacturers can maintain compliance and operational efficiency.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Our Mission at Voyager Therapeutics: Define the Future of Neurogenetic Medicines

BioSpace

We are in an unprecedented time in neurotherapeutics.

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New patent expiration for Bayer Healthcare drug ALIQOPA

Drug Patent Watch

Annual Drug Patent Expirations for ALIQOPA Aliqopa is a drug marketed by Bayer Healthcare and is included in one NDA. It is available from one supplier.

Drugs 52
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Opioid-Induced Adrenal Insufficiency

JAMA Internal Medicine

This case report describes a woman in her 40s with opioid use disorder receiving methadone who was admitted for extended antibiotic treatment for methicillin-resistant Staphylococcus aureus bacteremia and was subesequently diagnosed with opioid-induced adrenal insufficiency.

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New patent for Neurocrine drug ONGENTYS

Drug Patent Watch

Annual Drug Patent Expirations for ONGENTYS Ongentys is a drug marketed by Neurocrine and is included in one NDA. It is available from two suppliers.

Drugs 52
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Powder dosed drug patent expirations by year

Drug Patent Watch

This chart shows the patent expirations for powder dosed drugs over the next decade. The term of drug patents varies.

Drugs 52